Tests donor stem cell transplant and immunotherapy in high-risk neuroblastoma that has returned
Tests a donor stem cell transplant with immunotherapy in people whose high-risk neuroblastoma returned.
Key facts
- Who runs it
- IRCCS Istituto Giannina Gaslini
- Where
- Genoa, ItalySee the site
- Registry title
- TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 19 people, planned
- Started
- 29 Aug 2023
- Expected to end
- 31 Jul 2028
- Type of study
- Interventional
- Record updated
- 31 January 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people with high-risk neuroblastoma that came back or got worse after first treatment. They need a family donor with a half-matching tissue type for a stem cell transplant.
- Age
- Up to 64 years.
- Sex
- All sexes can join.
- Disease stage
- High-risk neuroblastoma: stage 4 with age over 12 months at diagnosis, or stage 2, 3, 4s with MYCN amplification. The disease came back or progressed after first-line treatment. It must be stable (at or above stable disease by INRC criteria) after salvage chemotherapy.
- Earlier treatment
- First-line treatment for neuroblastoma, then salvage chemotherapy that stabilised the disease.
- Biomarker or test result
- MYCN amplification for stage 2, 3 and 4s disease. A haploidentical family donor is needed for stem cell donation from peripheral blood.
Main reasons for not taking part
- Disease getting worse after salvage therapy
- Severe organ problems, grade 4 or higher (CTCAE v 5.0)
- Life expectancy of less than 3 months
The registry criteria, word for word
Show all 7 criteriaShow less
Who can take part
- High-risk neuroblastoma (stage 4 with age > 12 months at diagnosis, or stage 2, 3, 4s with MYCN amplification) in local, metastatic or combined recurrence after first-line therapy protocol
- Stabilization of disease (at or above STABLE DISEASE according to INRC criteria) achieved after salvage chemotherapy according to the center’s clinical practice
- Availability of a suitable HLA haploidentical familial donor to perform HSC donation from peripheral blood after stimulation with GCSF (+/-Plerixafor)
- Informed parental or legal guardian consent
Who cannot take part
- Disease progressing after salvage therapy
- Severe organ dysfunction, defined as grade 4 or higher dysfunctions according to international reference tables (CTCAE v 5.0)
- Life expectancy of less than 3 months
Where in Italy
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
About the trial
What the trial wants to find out
To evaluate the safety and efficacy of haploidentical stem cell transplantation with alfa-beta-CD19+ depletion folowed by immunotherapy with donor-NK cells infusion and anti-GD2 moAb in patients with high risk Neuroblastoma relapsed or in progression disease after first line treatment.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma
- Plain-language title
- Tests donor stem cell transplant and immunotherapy in high-risk neuroblastoma that has returnedGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 11 November 2026.
- Record updated
- 31 January 2025